Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial
Acute intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke, accounting for at least 10% of the 20 million new strokes in the world each year. Survivors are at high risk of recurrent ICH and other serious cardiovascular (CV) events. Whilst there is strong evidence that this risk can be reduced by lowering blood pressure (BP), as indicated by the results of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS) trial, many ICH patients do not receive any BP-lowering treatment, and if they do, they receive treatment such that their BP is inadequately controlled. The situation is driven by uncertainties regarding balance of benefits and risks of more intensive BP-lowering, and the requirement to take multiple BP-lowering agents to achieve adequate BP control. TRIDENT has been designed to resolve persisting clinical uncertainty and provide definitive evidence on the effectiveness of more intensive BP-lowering to prevent recurrent serious CV events after ICH using a simplified combination regimen of BP-lowering agents.
Multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial of a fixed low-dose combination BP-lowering pill (Triple Pill) on top of standard of care, in patients with a history of acute ICH and systolic BP (SBP) levels defined as at least ‘high normal to borderline high’ (defined as ≥130mmHg) and on either minimal or no BP-lowering treatment according to standard guideline definitions. The double-blind treatment period will be preceded by a 2-week, single-blind, active run-in phase in which all participants will receive the Triple Pill to ensure the randomisation of participants who tolerate the treatment regimen and procedures, thus increasing the likelihood of high adherence to the follow-up schedule. The study is event-driven and will last 5-10 years, with the average follow-up treatment period for participants being 3 years.